MAUDE Adverse Event Report: CARDINAL HELATH ENTFLX 12FR 43W OSTYL W Y PRT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	8884721237E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Vomiting (2144)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the feeding tube placed by interventional radiology easily migrated back up causing the patient to vomit and aspirate resulting in prolonged ventilator days due to aspiration.The patient had compounding co-morbidities such as previous gi surgery including stapling and was there for seizures which may have caused the tube to migrate up.The patient's family decided to put that patient on comfort care.
Additional Manufacturer Narrative
A sample was not received for the investigation.The device history records for the potential lot numbers were reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTFLX 12FR 43W OSTYL W Y PRT
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HELATH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16518862
• Report Number: 9612030-2023-03630
• Device Sequence Number: 3302100
• Product Code: PIF
• UDI-Device Identifier: 10884521583023
• UDI-Public: 10884521583023
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8884721237E
• Device Catalogue Number: 8884721237E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown